Recall of LIFESHIELD BURETTE SET CONVERTIBLE PIERCING PIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26221
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-26
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    There is potential for the float valve (automatic shut off valve) to stick to the burette wall causing the burette port to remain open after administration of iv fluids solutions. consequently there is potential to deliver air to patient.

Device

  • Model / Serial
    Model Catalog: 12722001 (Lot serial: 960985H)
  • Product Description
    100 mL Burette Set Convertible Pin77"
  • Manufacturer

Manufacturer

  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
  • Source
    HC